Senior Clinical Research Associate
Edgewise Therapeutics · United States
- Hybrid
- Full-time
- $140,000 / year
- United States
Job highlights
- Lead clinical trial startup and feasibility activities.
- Oversee CRO monitoring and site compliance.
- Manage study progress and identify operational challenges.
- Ensure data quality and regulatory compliance.
- Collaborate with internal teams and mentor new members.
About the role
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
Edgewise is headquartered in Boulder, Colorado; this is a position for a growing Colorado-based Clinical Development team. The assigned clinical trials will be highly complex and high risk, e.g. multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidates may be asked to provide support to the Edgewise clinical study lead for more than one study or across programs.
Key Responsibilities:
- Lead site start-up activities (e.g. oversight of CRO start-up activities, accountable for essential document package review, site initiation slide deck, vendor training, participate in remote/or on-site initiation visits) and contribute to feasibility, as required.
- Collaborate with contracts team to lead review and negotiation of site and vendor budgets/contracts.
- Contribute to the development and review of study, patient and site facing documents (e.g. protocols, ICFs and study plans).
- Oversee Edgewise contract CRA and/or CRO monitoring activities (e.g. visit schedules, monitoring visit reviews, monitoring plan review). May include on-site co-monitoring with CRO CRA, ensuring compliance with protocol and regulatory requirements. Provide additional clinical monitoring training support to CRO personnel, as needed. Attend CRO monitoring meetings. May include assigned monitoring responsibilities for sites.
- Review and oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits.
- Support the Edgewise clinical study lead in managing progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment and other tasks as assigned.
- Proactively review electronic data capture (EDC) for completion and to identify issues and generate queries.
- Identify and monitor risks and decisions at the study level and implementation of mitigation strategies. Identify potential operational challenges, and in collaboration with senior team members, provide guidance and solutions to ensure study execution remains on track.
- Contribute to drafting Standard Operating Procedures (SOPs) and adhere to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
- Responsible for the oversight of assigned vendors.
- Collaborate with internal teams (e.g. Clinical Operations, Regulatory Affairs, Data Management, Medical Monitoring, CMC, etc.) to ensure seamless trial execution and provide regular study updates to the appropriate internal stakeholders.
- May be accountable for reviewing site or vendor invoicing and financial management in accordance with the clinical trial agreement / scope of work.
- Support TMF activities as required (e.g. review of TMF index, document provision, etc.).
- Support onboarding and mentoring of new department members.
Required Education, Experience, Skills:
- At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences)
- Minimum 4 years of independent on-site monitoring experience (across all visit types and inclusive of remote monitoring), with at least 3 years cardiac study experience in a pharmaceutical sponsor environment preferred (global pharma or biotech preferred).
- Excellent attention to detail, verbal, written, interpersonal and presentation skills are required
- Must be familiar with routine medical/scientific terminology.
- Proficiency with MS Office required (inclusive of PPT), Smart Sheet proficiency desirable
- Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
- Highly productive, engaged and accountable
- Team-player desiring to work in a fast-moving, dynamic start-up environment
This is a full-time position (40 hours/week), hybrid, Colorado based preferred. 20-50% travel.
Salary range: $90,000 - $140,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
Key skills/competency:
- Clinical Research Associate
- Cardiovascular Studies
- On-site Monitoring
- Remote Monitoring
- GCP Compliance
- FDA Regulations
- ICH Guidelines
- Clinical Operations
- Data Management
- Protocol Deviations
Skills & topics
- Senior Clinical Research Associate
- Clinical Operations
- Cardiovascular
- Clinical Trials
- GCP
- ICH
- FDA
- Biotechnology
- Pharmaceutical
- Sponsor
How to get hired
- Tailor your resume: Highlight clinical operations experience, cardiovascular study expertise, and GCP/ICH knowledge.
- Craft a compelling cover letter: Emphasize your experience with on-site and remote monitoring and your ability to work in a startup environment.
- Prepare for behavioral questions: Be ready to discuss your attention to detail, problem-solving skills, and teamwork in a fast-paced setting.
- Understand Edgewise's mission: Research their focus on muscle disease and their goal to improve patient lives.
Technical preparation
Behavioral questions
Frequently asked questions
- What is the typical career progression for a Senior Clinical Research Associate at Edgewise Therapeutics?
- While specific paths may vary, a Senior Clinical Research Associate at Edgewise Therapeutics can expect opportunities to grow into lead roles within clinical development, potentially managing larger or more complex trials, or moving into leadership positions within the Clinical Operations department. The company's growth in the biopharmaceutical sector suggests potential for advancement as the team expands.
- What are the core therapeutic areas Edgewise Therapeutics focuses on, and how does the Senior CRA role contribute?
- Edgewise Therapeutics focuses on discovering and developing medicines for serious muscle diseases, specifically skeletal and cardiac muscle conditions. As a Senior Clinical Research Associate, you will play a crucial role in executing clinical trials within these therapeutic areas, ensuring the successful and compliant advancement of their product candidates from pre-clinical stages to market.
- How does Edgewise Therapeutics foster a team-player environment in their Clinical Development team?
- Edgewise Therapeutics emphasizes collaboration and a 'team-player' mentality, particularly within their growing Colorado-based Clinical Development team. This is reflected in the job description's call for collaboration with internal teams, support for senior team members, and the mentoring of new department members, all within a fast-moving startup environment.
- What is the expected travel percentage for the Senior Clinical Research Associate role at Edgewise Therapeutics?
- The Senior Clinical Research Associate position at Edgewise Therapeutics involves an estimated travel commitment of 20-50%. This travel would likely involve on-site monitoring visits, co-monitoring with CRO CRAs, and potentially attending CRO monitoring meetings or regulatory inspections.
- What kind of technology and tools are commonly used in clinical trials at Edgewise Therapeutics?
- Based on the job description, common tools include electronic data capture (EDC) systems for data review and query generation, MS Office suite (including PowerPoint) for documentation and presentations, and SmartSheet is mentioned as desirable. Familiarity with these platforms is beneficial for the Senior Clinical Research Associate role.
- How important is experience with specific study types, such as cardiac studies, for this Senior CRA role?
- Experience with cardiac studies is highly preferred for this Senior Clinical Research Associate position, with a requirement of at least 3 years of such experience in a pharmaceutical sponsor environment. This suggests a strong focus on cardiovascular research within Edgewise Therapeutics' pipeline.
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